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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Completed
Application Number P050006 / PAS001
Date Current Protocol Accepted 12/13/2006
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is prospective cohort study. The study population consists of two different cohorts: 1) Continued Access Study of the GORE HELEX Septal Occluder and 2) Post-Approval Study of the GORE HELEX Septal Occluder (CA-PAS Subjects HLX 06-04).
Study Population Description The GORE HELEX Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects. This study will enroll approximately 200 subjects, including subjects from the Icontinued Access Study, who have been successfully implanted.
Sample Size 200 patients, 19 sites
Data Collection Composite Clinical Success is evaluated at 12 months and is defined as a subject with the targeted defect assessed by TTE as being either completely occluded or the residual shunt is clinically insignificant, with an absence of repeat procedure to the target ASD, and absence of any major complication.
Follow-up Visits and Length of Follow-up The safety endpoints defined above will be evaluated annually through 5 years post procedure. The efficacy endpoints defined above will be evaluated at year 1, 3, and 5 post-procedure.During Year 2 and Year 4 of long-term follow-up, the site will contact the subject (or legal guardian if subject is a minor) by telephone to evaluate their status. During Year 3 and Year 5 of long-term follow-up, the site will schedule subject for a follow-up visit. Follow-up visit will include physical examination, ECG, and echocardiogram. A fluoroscopy exam without contrast will be conducted at Year 5.
Interim or Final Data Summary
Interim Safety Information No unanticipated adverse events have been reported to date. There have been no new Major Adverse Events reported during this reporting period. Clinically successful defect closure (Complete Occlusion or Clinically Insignificant Leak) was observed in 97.8% (43/44) of subjects evaluated at 12 months post procedure by the Echocardiographic Core Lab. Of the echo core lab reviews available for the 16 subjects at 36 months post procedure, clinically successful defect closure was observed in 100.0%. Of the 17 echo core lab reviews available for the 17 subjects at 60 months post procedure, clinically successful defect closure also was observed in 100.0%. Clinical Success was achieved in 85.0% (17/20) of subjects evaluated at 60 month post procedure. Three subjects were considered clinical failures. These are the same three (3) subjects identified at the 12 month post procedure interval. Clinical Success has been determined in 20 (40.0%) of the 50 evaluable subjects at the 60 month follow-up interval. Of the 30 subjects not evaluated, 15 were lost to follow-up and 15 have not completed Echo Core Lab evaluations of residual defect status (pending or missing).
Actual Number of Patients Enrolled Continued Access Study: 50

PAS: 215

Actual Number of Sites Enrolled Continued Access Study: 13

Post-approval Study (PAS): 21 sites

Patient Follow-up Rate Continued Access Study: 70% PAS: 76%
Final Safety Findings Continued Access Study:

Major adverse events were reported in 6.0% (3/50) of subjects. These included 2 device embolizations in the first 24 hours post-procedure and 1 wire frame fracture. All of these major adverse events were device-related and occurred within 12 months.


Major adverse events (MAEs) were reported in 4.7% (10/215) of subjects through the 60-month follow- up. Out of 8 device-related MAEs, there were 2 device embolizations within the first 30 days post- procedure and 5 device removals (4 due to fracture and 1 due to device malposition).

Final Effect Findings Continued Access Study:

Clinically successful defect closure was observed in 91.5% (43/47), 84.2% (16/19), and 87.5% (21/24) of subjects evaluated at 12, 36, and 60 months post-procedure, respectively.


Clinically successful defect closure was observed in 95.0% (171/180), 92.5% (123/133), and 94.1% (143/152) of subjects evaluated at 12, 36, and 60 months post-procedure, respectively.

Study Strengths & Weaknesses Continued Access Study: The 50 subjects in this study provided safety and efficacy data in support of the PMA approval for the Gore Helex septal occluder. Subjects in this study had to be re-consented for longer-term follow-up. Many of the subjects missed the 36-month follow-up and consequently, this information was not available for analysis. This also impacted the overall study follow-up. Analysis presented showed no evidence of selection bias introduced in the study due to loss-to-follow-up. This study shows the initial results of the long-term performance of this device.


The results of this study provide long-term safety and effectiveness data for the Gore Helex septal occluder. Although patient follow-up was 76%, only 4% shy of the protocol defined expectations, a sensitivity analysis showed no evidence of selection bias. Further, the data demonstrated that over 90% of the patients implanted with the investigational device maintained composite clinical success through

60 months.

Recommendations for Labeling Changes It is not recommended because W.L. Gore & Associates, Inc. ceased the production of the GORE HELEX Septal Occluder.


Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 02/12/2007 02/12/2007 On Time
1 year report 08/11/2007 07/19/2007 On Time
2 year report 08/11/2008 08/11/2008 On Time
3 year report 08/10/2009 08/04/2009 On Time
4 year report 08/10/2010 07/16/2010 On Time
5 year report 08/10/2011 07/16/2010 On Time
6 year report 08/09/2012 07/18/2011 On Time
7 year report 08/10/2012 08/01/2012 On Time
8 year report 08/10/2013 08/05/2013 On Time
9 year report 08/11/2014 08/08/2014 On Time
Final report 03/11/2015 03/09/2015 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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